
The Auditing Group &
The Validation Group
US Headquarters - In-Country China, India & South America GMP/GLP/GCP Auditors for Suppliers, CMOs and 'For-Cause' Audits!
01-856-437-5880
GMP - GCP - GLP - ISO
Global Auditing & Remediation Services
FDA, EMA, ISO Mock & PAI Audits
Vendors & Supplier Audits
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GMP/GLP/GCP GXP Audits - Excipients / APIs
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Medical Device - QMS/QSR Audits - ISO 13485:2016
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Vendor - Supplier Audits, CMOs, CDMOs
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Laboratory Audits - GLP/GCLP - Part 58/OECD GLP
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21 CFR Part 11 Systems & Software Compliance
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Validation Audits / Writing - Process & Equipment
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Dietary Supplements & Cosmetics Manufacturing
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Company Acquisitions & Compliance Audits
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Mock FDA, EU, NMPA & WHO Audits
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Remediation, Validation & Gap Analysis Reports
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Clinical Audits, CROs, GCLP, Investigator Sites

GxP Audits
All Subject Matter Experts (SMEs) have the Experience, Training, Education and Background to support your compliance audit and remediation requirements backed by TAG, ASQ and Global Accepted Certifications!
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GMP Audits - API/Excipients
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GLP Audits - QC, Testing and LIMs,
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Mock FDA/EMA, PAI, Pre-ISO
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Vendors, Suppliers and Contractors
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Pharmaceuticals / Supplements
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Medical Devices / IVDs
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Cosmetics
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Biologics, Blood, Cell, Tissue
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Validation Audits
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Engineering Audits
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Document Audits
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Clinical Audits
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Investigator Sites
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Clinical Data Management
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Clinical Electronic Systems
Remediation
The Auditing Group SMEs have the Experience to assist with your remediation efforts, whether satisfying a 'For-Cause' US FDA 483, Agency Warning Letter, or audit observations, we have the resources and tools to assist with your successful compliance endeavors.
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Project Management
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CAPA Management
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Procedure Development
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Protocol Development
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Design / Build Engineering Analysis
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As-Built Qualifications
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Commissioning and Qualifications
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Validation Services
Turn-key or Hourly SME Quotes!
Gantt Driven Project Management
Training
The Auditing Group has teamed up with GMP Boot Camps to provide on-site or Virtual training for your Employees to satisfy your GxP requirements.
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Basic 1, 2, or 3-day GMP / QMS for Drug, Medical Device, Cosmetics or Dietary Supplements Training
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Focused Training Programs - Taylored to your Company's Products, Services or Capabilities - Includes an on-site pre-training Audit of your GXP Compliance for training applicability.


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